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Trial Title: A Study of Tumor Imaging With Multispectral Optoacoustic Tomography

NCT ID: NCT05488483

Condition: Breast Cancer
Melanoma

Conditions: Official terms:
Melanoma

Conditions: Keywords:
Multispectral Optoacoustic Tomography Imaging
MSOT
Memorial Sloan Kettering Cancer Center
21-374

Study type: Observational

Overall status: Active, not recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Diagnostic Test
Intervention name: Multispectral Optoacoustic Tomography Imaging
Description: Each participants will undergo MSOT imaging of the suspicious breast tumor detected with ultrasound imaging and any additional lesion present in either breast before undergoing ultrasound-guided breast biopsy as the standard of care. Melanoma participants with pathologically confirmed ITM will undergo MSOT imaging following physical exam and biopsy. Melanoma patients receiving immunotherapy will undergo MSOT imaging prior to and following immunotherapy.
Arm group label: Breast and Melanoma Cohort

Other name: MSOT

Summary: Participants in this study will have Multispectral Optoacoustic Tomography/MSOT imaging of both breasts immediately before their ultrasound-guided breast biopsy procedure begins. After the MSO imaging is completed, participation in the study will end.

Criteria for eligibility:

Study pop:
Participants with a suspicious breast imaging finding detected on either mammography, ultrasound or MRI that is visible on ultrasound and therefore recommended for ultrasound-guided breast biopsy (BI-RADS 4 suspicious abnormality; BI-RADS 5, highly suggestive for malignancy) who are scheduled for ultrasound-guided breast biopsy by the Memorial Sloan Kettering Department of Radiology Breast Imaging Service will be included.

Sampling method: Non-Probability Sample
Criteria:
Inclusion Criteria: - Participant is a female or male who is 18 years of age or older. - Participant must meet one of the following: - Suspicious breast imaging finding detected on either mammography, ultrasound, or MRI that is visible on ultrasound and therefore recommended for ultrasound-guided breast biopsy (BI-RADS 4 suspicious abnormality; BI-RADS 5, highly suggestive for malignancy) - No previous treatment for breast cancer - Diagnosis of melanoma Exclusion Criteria: - Life expectancy < 3 months

Gender: Female

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: Memorial Sloan Kettering Bergen (Consent only )

Address:
City: Montvale
Zip: 07645
Country: United States

Facility:
Name: Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Consent only)

Address:
City: Commack
Zip: 11725
Country: United States

Facility:
Name: Memorial Sloan - Kettering Cancer Center

Address:
City: New York
Zip: 10021
Country: United States

Facility:
Name: Helmholtz Institute (Data Analysis Only)

Address:
City: Munich
Country: Germany

Start date: July 27, 2022

Completion date: July 27, 2025

Lead sponsor:
Agency: Memorial Sloan Kettering Cancer Center
Agency class: Other

Source: Memorial Sloan Kettering Cancer Center

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05488483
http://www.mskcc.org

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